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FDA Approves Durvalumab for Frontline Small Cell Lung Cancer

In Clinical Studies News by Barbara Jacoby

By: Gina Columbus From: onclive.com The FDA has approved durvalumab (Imfinzi) for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) for use in combination with standard-of-care chemotherapy, including etoposide plus either carboplatin or cisplatin.1 The approval is based on findings from phase III CASPIAN trial, in which adding the PD-L1 inhibitor to chemotherapy reduced the …

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AbbVie, Roche leukemia drug successful in Phase III confirmatory study

In Clinical Studies News by Barbara Jacoby

By: Alaric DeArment From: medcitynews.com The companies said Venclexta extended overall survival in untreated acute myeloid leukemia patients when combined with Bristol-Myers Squibb’s VidazaVenclexta. A prior Phase III confirmatory trial, combining the drug with low-dose cytarabine, failed. A cancer drug made by Chicago-based AbbVie and Swiss drugmaker Roche was successful in a Phase III confirmatory trial in an aggressive form …

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BRCA1/2-Positive Breast Cancer Patients May Respond to Certain Chemotherapy Regimens, Study Finds

In Clinical Studies News by Barbara Jacoby

By: Staff Reporter From: precisiononcologynews.com Researchers have homed in on BRCA1/2 mutations as a potential biomarker predictive of which early-stage breast cancer patients will respond to a neoadjuvant chemotherapy regimen containing epirubicin, paclitaxel, cyclophosphamide (iddEPC). Esther Pohl-Rescigno from University Hospital Cologne in Germany led the study published in JAMA Oncology last week. The secondary analysis was based on the 961-patient …

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FDA Accepts BLA for Pertuzumab/Trastuzumab Combo for HER2+ Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: JASON M. BRODERICK From: ncnursingnews.com The FDA has accepted a Biologics License Application (BLA) for a fixed-dose combination (FDC) of pertuzumab (Perjeta) and trastuzumab (Herceptin) with hyaluronidase, administered by subcutaneous (SC) injection in combination with intravenous (IV) chemotherapy, for the treatment of eligible patients with HER2-positive breast cancer.1 The BLA is based on data from the phase III FeDeriCa …

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GSK’s sNDA for Ovarian Cancer Drug Zejula Accepted by FDA

In Clinical Studies News by Barbara Jacoby

By: Staff Reporter From: precisiononcologynews.com GlaxoSmithKline said Monday that the supplemental new drug application for niraparib (Zejula) as a first-line maintenance treatment for chemotherapy-responsive advanced ovarian cancer was accepted by the US Food and Drug Administration. GSK is seeking approval for the drug in an all-comer patient population, regardless of whether they have tumors that are homologous recombination deficient (HRD). …

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Nodal Involvement Impacts Surgical Management of Axilla in Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Caroline Seymour From: onclive.com A sentinel node biopsy is a less-intensive alternative to a complete axillary lymph node dissection in breast cancer, but it is not appropriate for every patient with lymph node involvement, according to Hernan Vargas, MD, FACS, and the decision between the 2 approaches is grounded in the patient’s initial treatment intervention. “Axillary dissection has been …

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FDA Approves Neratinib Combo for HER2+ Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Gina Columbus From: onclive.com The FDA has approved a supplemental new drug application (sNDA) for neratinib (Nerlynx) in combination with capecitabine (Xeloda) for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received ≥2 prior anti–HER2-based regimens in the metastatic setting.1 The approval is based on findings from the phase III NALA trial, which …

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OncotypeDX Score May Give Valuable Info on Breast Cancer Locoregional Recurrence

In Clinical Studies News by Barbara Jacoby

By: Staff Reporter From: precisiononcologynews.com Researchers at the MD Anderson Cancer Center, Loyola University Chicago Stritch School of Medicine, and elsewhere have determined that a breast cancer recurrence score provided by the Genomic Health 21-gene expression assay OncotypeDX may provide valuable prognostic information on locoregional disease recurrence that may aid in decision-making about radiotherapy for postmenopausal women with node-positive, estrogen …

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Immunotherapeutic Agents Expand Treatment Landscape for Triple-Negative Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Danielle Ternyila From: targetedonc.com Patients with advanced or metastatic PD-L1–positive triple-negative breast cancer (TNBC) can now be treated with the FDA-approved combination of atezolizumab (Tecentriq) plus nab-paclitaxel (Abraxane) in the frontline setting, based on data from the phase III IMpassion130 trial (NCT02425891). According to Elizabeth Mittendorf, MD, PhD, this is a monumental improvement for the treatment of patients with …

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Neoadjuvant Systemic Therapy Improves Eligibility for Breast-Conserving Surgery in TNBC

In Clinical Studies News by Barbara Jacoby

By: Danielle Ternyila From: targetedonc.com Neoadjuvant systemic therapy may enable patients with triple-negative breast cancer (TNBC) who are ineligible for breast conservation therapy (BCT) to become eligible, according to a prespecified secondary analysis of the results from the phase III BrighTNess trial. “Surgical results from the BrighTNess trial demonstrate that neoadjuvant chemotherapy makes breast conservation possible in half of patients …